EXJADE® (deferasirox) tablets for oral suspension

Important Safety Information, including Boxed WARNING:

What is the most important safety information to know about EXJADE?

EXJADE may cause serious kidney problems, liver problems, and bleeding in the stomach or intestines. In some cases, these problems were fatal. Kidney problems occurred particularly in patients with multiple medical conditions and those who were very ill because of their disease. Bleeding in the stomach or intestines occurred more often in elderly patients. Liver problems were more likely to happen in patients older than 55 years.

If you already have a history of kidney problems, or are at risk for kidney problems, your doctor should check your kidneys:

Every week for the first month

Monthly during treatment

Your doctor should check your liver function with blood tests:

Before taking EXJADE

Every other week for the first month after starting EXJADE

Monthly during treatment

You should not take EXJADE if you have:

Certain kinds of kidney problems

Preexisting severe liver problems

High-risk myelodysplastic syndromes (MDS)

Advanced cancer

Low blood counts (low platelets)

An allergy to EXJADE or any ingredient of EXJADE

Kidneys

If you have a preexisting kidney condition, are elderly, have multiple medical conditions, or are taking medicine that affects your kidneys, you are at increased risk of complications. Your doctor will do blood tests (serum creatinine and/or creatinine clearance, estimated glomerular filtration rate (eGFR), and serum electrolytes) every week for the first month you are taking EXJADE or if your dose has changed, and then every month after that. Your doctor may adjust your dose based on the results of these tests

Your doctor will also collect urine samples monthly

Some patients developed severe kidney problems while taking EXJADE, in some cases fatal, and in some cases requiring dialysis. Most of the fatalities occurred in patients who were very ill because of their disease

In younger patients, stop taking EXJADE during serious illness that can cause dehydration such as vomiting, diarrhea, or prolonged decreased oral intake

Liver

If you have a preexisting severe liver problem, you should not use EXJADE

If you have mild or moderate liver problems, your doctor will do blood tests (serum transaminases and bilirubin) before starting treatment, every 2 weeks during the first month of treatment, and then monthly. Your doctor may adjust your dose based on the results of these tests

Some patients developed severe liver problems, in some cases fatal, while taking EXJADE. Many of these patients were older than 55 years of age and/or had multiple medical conditions already affecting their liver

Bleeding in the Stomach or Intestines

Some patients developed stomach irritation or bleeds while taking EXJADE. In some cases, stomach bleeds were fatal, usually in patients who were elderly and had preexisting blood cancers and/or low blood counts (low platelets)

Talk to your doctor if you are taking other drugs that can also irritate your stomach or cause a stomach bleed (eg, pain relievers/anti-inflammatory drugs, corticosteroids, oral bisphosphonates, or blood thinners)

Blood Disorders

Some patients developed severe blood disorders, in some cases fatal, while on EXJADE therapy. Having a preexisting blood disorder may increase the risk

Your doctor will do a blood test to check your blood counts

Increased Risks With Different Ages

Elderly Patients: Since EXJADE has been on the market, there have been reports of serious reactions, sometimes leading to death. These serious reactions and deaths have happened most often when EXJADE was taken by elderly patients

Pediatric Patients: Serious and fatal events have occurred in pediatric patients. These were associated with dehydration or when dosing is continued when the iron burden is in the normal range

Allergic Reactions

Serious allergic reactions (which include swelling of the throat) have been reported in patients taking EXJADE, usually within the first month of treatment

If you develop swelling of the throat, a severe rash, hearing problems, or vision disturbances, stop taking EXJADE and contact your doctor immediately

Serious Skin Reactions

Severe skin disorders that result in a very serious rash, called Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and erythema multiforme, have been reported during treatment with EXJADE. Other skin reactions, including DRESS (drug reaction with eosinophilia and systemic symptoms), can also occur. If you develop a severe rash, stop taking EXJADE and contact your doctor immediately

Mild to moderate skin rashes may occur during treatment with EXJADE. Let your doctor know if the rash doesn’t go away on its own or gets worse. Your doctor may need to change your dose of EXJADE

Hearing and Vision Changes

Changes to hearing and vision have been reported in patients taking EXJADE. If you notice changes in your hearing or eyesight, contact your doctor immediately

You may also receive a hearing or vision test prior to receiving EXJADE, and yearly thereafter. Your doctor may change your dose based on the results of these tests

Let your doctor know if you are experiencing any side effects. Your doctor may need to change your dose

If you experience diarrhea or vomiting, you must continue to drink fluids

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088

Taking Other Medicines and EXJADE

If you are taking other medicines such as birth control pills, diabetes drugs, seizure drugs, cholesterol-lowering drugs, or medicine for serious illnesses, talk to your doctor. EXJADE may affect how these drugs work

Talk to your doctor to determine if prescription EXJADE therapy is right for you.

Please see full Prescribing Information, including Boxed WARNING, for EXJADE® (deferasirox) tablets for oral suspension.

Approved Use:

Treatment of Chronic Iron Overload Due to Blood Transfusions (Transfusional Iron Overload) EXJADE® (deferasirox) tablets for oral suspension is indicated for the treatment of chronically elevated levels of iron in the blood caused by repeated blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older.

Limitation on the Use of EXJADE

It is not known if EXJADE is safe or effective when taken with another therapy that lowers iron levels in the blood.

EXJADE may cause serious kidney problems, liver problems, and bleeding in the stomach or intestines. In some cases, these problems were fatal. Kidney problems occurred particularly in patients with multiple medical conditions and those who were very ill because of their disease. Bleeding in the stomach or intestines occurred more often in elderly patients. Liver problems were more likely to happen in patients older than 55 years.

If you already have a history of kidney problems, or are at risk for kidney problems, your doctor should check your kidneys:

Every week for the first month

Monthly during treatment

Your doctor should check your liver function with blood tests:

Before taking EXJADE

Every other week for the first month after starting EXJADE

Monthly during treatment

You should not take EXJADE if you have:

Certain kinds of kidney problems

Preexisting severe liver problems

High-risk myelodysplastic syndromes (MDS)

Advanced cancer

Low blood counts (low platelets)

An allergy to EXJADE or any ingredient of EXJADE

Kidneys

If you have a preexisting kidney condition, are elderly, have multiple medical conditions, or are taking medicine that affects your kidneys, you are at increased risk of complications. Your doctor will do blood tests (serum creatinine and/or creatinine clearance, estimated glomerular filtration rate (eGFR), and serum electrolytes) every week for the first month you are taking EXJADE or if your dose has changed, and then every month after that. Your doctor may adjust your dose based on the results of these tests

Your doctor will also collect urine samples monthly

Some patients developed severe kidney problems while taking EXJADE, in some cases fatal, and in some cases requiring dialysis. Most of the fatalities occurred in patients who were very ill because of their disease

In younger patients, stop taking EXJADE during serious illness that can cause dehydration such as vomiting, diarrhea, or prolonged decreased oral intake

Liver

If you have a preexisting severe liver problem, you should not use EXJADE

If you have mild or moderate liver problems, your doctor will do blood tests (serum transaminases and bilirubin) before starting treatment, every 2 weeks during the first month of treatment, and then monthly. Your doctor may adjust your dose based on the results of these tests

Some patients developed severe liver problems, in some cases fatal, while taking EXJADE. Many of these patients were older than 55 years of age and/or had multiple medical conditions already affecting their liver

Bleeding in the Stomach or Intestines

Some patients developed stomach irritation or bleeds while taking EXJADE. In some cases, stomach bleeds were fatal, usually in patients who were elderly and had preexisting blood cancers and/or low blood counts (low platelets)

Talk to your doctor if you are taking other drugs that can also irritate your stomach or cause a stomach bleed (eg, pain relievers/anti-inflammatory drugs, corticosteroids, oral bisphosphonates, or blood thinners)

Blood Disorders

Some patients developed severe blood disorders, in some cases fatal, while on EXJADE therapy. Having a preexisting blood disorder may increase the risk

Your doctor will do a blood test to check your blood counts

Increased Risks With Different Ages

Elderly Patients: Since EXJADE has been on the market, there have been reports of serious reactions, sometimes leading to death. These serious reactions and deaths have happened most often when EXJADE was taken by elderly patients

Pediatric Patients: Serious and fatal events have occurred in pediatric patients. These were associated with dehydration or when dosing is continued when the iron burden is in the normal range

Allergic Reactions

Serious allergic reactions (which include swelling of the throat) have been reported in patients taking EXJADE, usually within the first month of treatment

If you develop swelling of the throat, a severe rash, hearing problems, or vision disturbances, stop taking EXJADE and contact your doctor immediately

Serious Skin Reactions

Severe skin disorders that result in a very serious rash, called Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and erythema multiforme, have been reported during treatment with EXJADE. Other skin reactions, including DRESS (drug reaction with eosinophilia and systemic symptoms), can also occur. If you develop a severe rash, stop taking EXJADE and contact your doctor immediately

Mild to moderate skin rashes may occur during treatment with EXJADE. Let your doctor know if the rash doesn’t go away on its own or gets worse. Your doctor may need to change your dose of EXJADE

Hearing and Vision Changes

Changes to hearing and vision have been reported in patients taking EXJADE. If you notice changes in your hearing or eyesight, contact your doctor immediately

You may also receive a hearing or vision test prior to receiving EXJADE, and yearly thereafter. Your doctor may change your dose based on the results of these tests

Let your doctor know if you are experiencing any side effects. Your doctor may need to change your dose

If you experience diarrhea or vomiting, you must continue to drink fluids

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088

Taking Other Medicines and EXJADE

If you are taking other medicines such as birth control pills, diabetes drugs, seizure drugs, cholesterol-lowering drugs, or medicine for serious illnesses, talk to your doctor. EXJADE may affect how these drugs work

Talk to your doctor to determine if prescription EXJADE therapy is right for you.

Please see full Prescribing Information, including Boxed WARNING, for EXJADE® (deferasirox) tablets for oral suspension.

Approved Use:

Treatment of Chronic Iron Overload Due to Blood Transfusions (Transfusional Iron Overload) EXJADE® (deferasirox) tablets for oral suspension is indicated for the treatment of chronically elevated levels of iron in the blood caused by repeated blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older.

Limitation on the Use of EXJADE

It is not known if EXJADE is safe or effective when taken with another therapy that lowers iron levels in the blood.

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FINANCIAL ASSISTANCE MAY BE AVAILABLE FOR EXJADE

You may be eligible for immediate co-pay savings on your next prescription of EXJADE:

Eligible patients with private insurance may pay $0 per month

Novartis will pay the remaining co-pay, up to $15,000 per calendar year, per product*

*Limitations apply. This offer is only available to patients with private insurance. The program is not available for patients who are enrolled in Medicare, Medicaid, or any other federal or state health care program. Offer is NOT valid for Massachusetts residents. In order to comply with California law, additional program restrictions apply to California residents seeking to use the program. Patients that are residents of California please call1-877-577-7756 to discuss eligibility with a program counselor. Novartis reserves the right to rescind, revoke, or amend this program without notice. For full Terms and Conditions, visit Copay.NovartisOncology.com or call 1-877-577-7756.

PATIENT ASSISTANCE NOW ONCOLOGY

Our Patient Assistance Now Oncology (PANO) program was created to assist you with accessing your Novartis medicine(s)—from insurance verification to financial assistance—all through a knowledgeable and supportive call center.

Program overview

Novartis Oncology is committed to helping you get the Novartis medicine(s) you need. Access to medicine(s) can sometimes be difficult or confusing. PANO offers resources and support designed specifically to help make that process easier.*

PANO offers the following services:

Help with understanding your insurance coverage and financial responsibilities throughout the insurance verification process

Aid with identifying the pharmacies covered by your insurance plan

Insurance and Medicare education

Information about financial assistance that may be available

Patient Support Counselors who are able to provide information in more than 160 languages

One single point of contact to help guide you through getting access to the Novartis medicine(s) prescribed by your doctor

*Novartis Pharmaceuticals Corporation does not guarantee success in obtaining reimbursement or financial assistance. Third-party payment for medical products and services is affected by numerous factors, not all of which can be anticipated or resolved.

EXJADE® (deferasirox) tablets for oral suspension is indicated for the treatment of chronically elevated levels of iron in the blood caused by repeated blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older.

Limitation on the Use of EXJADE

It is not known if EXJADE is safe or effective when taken with another therapy that lowers iron levels in the blood.

Important Safety Information, including Boxed WARNING:

What is the most important safety information to know about EXJADE?EXJADE may cause serious kidney problems, liver problems, and bleeding in the stomach or intestines. In some cases, these problems were fatal. Kidney problems occurred particularly in patients with multiple medical conditions and those who were very ill because of their disease. Bleeding in the stomach or intestines occurred more often in elderly patients. Liver problems were more likely to happen in patients older than 55 years.

If you already have a history of kidney problems, or are at risk for kidney problems, your doctor should check your kidneys:

Every week for the first month

Monthly during treatment

Your doctor should check your liver function with blood tests:

Before taking EXJADE

Every other week for the first month after starting EXJADE

Monthly during treatment

You should not take EXJADE if you have:

Certain kinds of kidney problems

Preexisting severe liver problems

High-risk myelodysplastic syndromes (MDS)

Advanced cancer

Low blood counts (low platelets)

An allergy to EXJADE or any ingredient of EXJADE

Kidneys

If you have a preexisting kidney condition, are elderly, have multiple medical conditions, or are taking medicine that affects your kidneys, you are at increased risk of complications. Your doctor will do blood tests (serum creatinine and/or creatinine clearance, estimated glomerular filtration rate (eGFR), and serum electrolytes) every week for the first month you are taking EXJADE or if your dose has changed, and then every month after that. Your doctor may adjust your dose based on the results of these tests

Your doctor will also collect urine samples monthly

Some patients developed severe kidney problems while taking EXJADE, in some cases fatal, and in some cases requiring dialysis. Most of the fatalities occurred in patients who were very ill because of their disease

In younger patients, stop taking EXJADE during serious illness that can cause dehydration such as vomiting, diarrhea, or prolonged decreased oral intake

Liver

If you have a preexisting severe liver problem, you should not use EXJADE

If you have mild or moderate liver problems, your doctor will do blood tests (serum transaminases and bilirubin) before starting treatment, every 2 weeks during the first month of treatment, and then monthly. Your doctor may adjust your dose based on the results of these tests

Some patients developed severe liver problems, in some cases fatal, while taking EXJADE. Many of these patients were older than 55 years of age and/or had multiple medical conditions already affecting their liver

Bleeding in the Stomach or Intestines

Some patients developed stomach irritation or bleeds while taking EXJADE. In some cases, stomach bleeds were fatal, usually in patients who were elderly and had preexisting blood cancers and/or low blood counts (low platelets)

Talk to your doctor if you are taking other drugs that can also irritate your stomach or cause a stomach bleed (eg, pain relievers/anti-inflammatory drugs, corticosteroids, oral bisphosphonates, or blood thinners)

Blood Disorders

Some patients developed severe blood disorders, in some cases fatal, while on EXJADE therapy. Having a preexisting blood disorder may increase the risk

Your doctor will do a blood test to check your blood counts

Increased Risks With Different Ages

Elderly Patients: Since EXJADE has been on the market, there have been reports of serious reactions, sometimes leading to death. These serious reactions and deaths have happened most often when EXJADE was taken by elderly patients

Pediatric Patients: Serious and fatal events have occurred in pediatric patients. These were associated with dehydration or when dosing is continued when the iron burden is in the normal range

Allergic Reactions

Serious allergic reactions (which include swelling of the throat) have been reported in patients taking EXJADE, usually within the first month of treatment

If you develop swelling of the throat, a severe rash, hearing problems, or vision disturbances, stop taking EXJADE and contact your doctor immediately

Serious Skin Reactions

Severe skin disorders that result in a very serious rash, called Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and erythema multiforme, have been reported during treatment with EXJADE. Other skin reactions, including DRESS (drug reaction with eosinophilia and systemic symptoms), can also occur. If you develop a severe rash, stop taking EXJADE and contact your doctor immediately

Mild to moderate skin rashes may occur during treatment with EXJADE. Let your doctor know if the rash doesn’t go away on its own or gets worse. Your doctor may need to change your dose of EXJADE

Hearing and Vision Changes

Changes to hearing and vision have been reported in patients taking EXJADE. If you notice changes in your hearing or eyesight, contact your doctor immediately

You may also receive a hearing or vision test prior to receiving EXJADE, and yearly thereafter. Your doctor may change your dose based on the results of these tests

If you are taking other medicines such as birth control pills, diabetes drugs, seizure drugs, cholesterol-lowering drugs, or medicine for serious illnesses, talk to your doctor. EXJADE may affect how these drugs work

Talk to your doctor to determine if prescription EXJADE therapy is right for you.

Please see full Prescribing Information, including Boxed WARNING, for EXJADE® (deferasirox) tablets for oral suspension.

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